Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain

Shock Wave Therapy for Sural Myofascial Pain Syndrome Associated With Plantar Fasciitis: a Pilot Randomized Controlled Trial

The aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural myofascial pain syndrome.

Study Overview

• Status: Completed
• Conditions: Tendinopathy
• Intervention / Treatment: Other: Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points; Other: Shock wave therapy on plantar fascia only

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult age (18 to 75 years) and written informed consent;
• Unilateral heel pain of four weeks or longer duration;
• Pain to digital pressure in the insertional area of the plantar fascia at the calcaneum;
• Sonographic examination showing a plantar fascia thickness greater than 3.8mm (see procedures for details);
• Concomitant presence of a sural myofascial pain syndrome (SMPS), diagnosed on the basis of the finding, at the physical examination, of trigger points of the gastrocnemius-soleus muscle complex, according to Travel and Simons' original description.

Exclusion Criteria:

• No corticosteroid injections or other physical therapies since the onset of the current pain episode (except pharmacological pain treatments and foot orthoses);
• No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area);
• No clinical signs of lumbar radiculopathy at physical examination;
• No ankle osteoarthritis, diagnosed on the basis of clinical and radiographic findings;
• No previous fractures or surgery in the affected ankle and foot;
• No rheumatologic diseases, no plantar fibromatosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group:shock waves extended to gastrocnemius TrP; Focused shock wave therapy was extended from the plantar fascia to the gastrocnemius-soleus trigger points.	Other: Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points; Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia and the gastrocnemius-soleus trigger points were clinically targeted and treated with a perpendicular technique.
Active Comparator: Control group: shock waves not extended to gastrocnemius TrP; A standard focused shock wave therapy exclusively targeted at the plantar fascia	Other: Shock wave therapy on plantar fascia only; Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia was clinically targeted and treated with a perpendicular technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FFI-foot function index	Foot Function Index is self-administered questionnaire designed to measure foot performances in relation to symptoms. Foot Function Index is structured in two sections of nine items each, investigating foot pain (FFI-A) and function (FFI-B) respectively. The total score of each section ranges from zero (no pain/no functional limitation) to 100 (intolerable pain/complete inability). The two scores were separately analysed.	FFI was administered at baseline, at two months time point and at three months time point

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PPT-pressure pain threshold	Pressure pain threshold (PPT) of the gastrocnemius-soleus trigger points was assessed by means of a digital hand-held algometer (see procedures for details). PPT is the minimal force that induces pain and its measurement is useful to quantitatively evaluate the effect of a treatment on trigger points	PPT was recorded at baseline, at two months time point and at three months time point

Collaborators and Investigators

• Sponsor: Foundation IRCCS San Matteo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2016
• Primary Completion (Actual): July 4, 2018
• Study Completion (Actual): November 3, 2018

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Myofascial pain syndrome
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Myofascial Pain Syndromes
• Other Study ID Numbers: 20160017179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No